Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

NCT ID: NCT05308836

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2024-12-30

Brief Summary

The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in patients with type 1 diabetes mellitus (T1D)

Detailed Description

Adipose derived mesenchymal stem cells (AD-MSCs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in treatment 10 patients with type 1 diabetes mellitus (T1D) at Vinmec International Hospital, Hanoi, Vietnam.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adipose-derived messenchymal stem cell (AD-MSC)

Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus.

Group Type: EXPERIMENTAL

adipose-derived messenchymal stem cell

Intervention Type: COMBINATION_PRODUCT

Collaborative research program between Vinmec Research Institute of Stem Cell and Gene Technology with the National Yang-Ming University in Taiwan The adipose mesenchymal stem cell line (GXIPC1) was collected from healthy donors who have screened for infectious diseases and then multiplied in large numbers. These products were produced following the GMP laboratory system and approved by Taiwan FDA for preclinical and clinical trials with completed certificates

Interventions

adipose-derived messenchymal stem cell

Collaborative research program between Vinmec Research Institute of Stem Cell and Gene Technology with the National Yang-Ming University in Taiwan The adipose mesenchymal stem cell line (GXIPC1) was collected from healthy donors who have screened for infectious diseases and then multiplied in large numbers. These products were produced following the GMP laboratory system and approved by Taiwan FDA for preclinical and clinical trials with completed certificates

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)
• Aged from 5 years and over.
• The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
• Blood testing conducted at the time of diagnosis:

• Fasting blood glucose ≥ 7 mmol / L,
• HbA1C ≥ 6.5%.
• Have at least one antibodies associated with T1D such as ICA; GAD; ZnT8 or IAA.
• At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.
• The patient does not have other serious acute illness requiring treatment
• The patient agrees to use stem cell transplant for treatment
• The patient's parent (parent or legal guardian) can read, write, understand the ICF form and agree to sign a consent to participate in the study.

Exclusion Criteria

• Having evidence related to renal dysfunction: creatinine > 1.5 mg/dl or (>133 mmol/L) for boys, creatinine > 1.4 mg/dl or (>124 mmol/L) for girls
• In case of kidney failure. Proteinuria within the range of nephrotic syndrome (>3.5 g/day or ratio of protein/creatinine in urine >2.7)
• In case of kidney failure
• Having severe infection or infected with hepatitis B virus, hepatitis C virus, HIV virus, or tuberculosis
• Cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease
• Blood clotting disorders (INR> 1,5, PTT> 40, PT> 15).
• Taking any anticoagulant
• Taking systemic steroids
• Participate in another clinical study involving experimenting drugs and/or medical equipment
• History of allergic reaction to anesthetic agents and/or antibiotics

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gwoxi Stem cell applied technology Company

UNKNOWN

Sponsor Role: collaborator

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liem T Nguyen, Prof

Role: PRINCIPAL_INVESTIGATOR

Vinmec Research Institute of Stem Cell and Gene Technology

Locations

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, , Vietnam

Countries

Vietnam

References

Zhang Y, Chen W, Feng B, Cao H. The Clinical Efficacy and Safety of Stem Cell Therapy for Diabetes Mellitus: A Systematic Review and Meta-Analysis. Aging Dis. 2020 Feb 1;11(1):141-153. doi: 10.14336/AD.2019.0421. eCollection 2020 Feb.

Reference Type: BACKGROUND

PMID: 32010488 (View on PubMed)

Araujo DB, Dantas JR, Silva KR, Souto DL, Pereira MFC, Moreira JP, Luiz RR, Claudio-Da-Silva CS, Gabbay MAL, Dib SA, Couri CEB, Maiolino A, Rebelatto CLK, Daga DR, Senegaglia AC, Brofman PRS, Baptista LS, Oliveira JEP, Zajdenverg L, Rodacki M. Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study. Front Immunol. 2020 Jun 2;11:993. doi: 10.3389/fimmu.2020.00993. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32582156 (View on PubMed)

Other Identifiers

ISC20.01

Identifier Type: -

Identifier Source: org_study_id